Temperature Controlled Transport – the Invisible Hero of Clinical Trials

Clinical trials are the crucial step that turn the possibility of ground-breaking medicines or treatments into a reality, changing countless of lives for the better. With thousands of trials taking place across the globe at any one time, have you ever stopped to consider the journey that these vital medicines take?

Throughout the course of a clinical trial, pharmaceutical samples or biological products can travel vast distances, often by land, air and sea. This is where temperature control transport becomes an invisible hero, helping us safeguard the integrity and efficacy of those precious materials.

In this article, we look at the key logistic considerations to ensure the successful transportation of pharmaceutical products and biological samples in clinical trials, highlighting the critical role temperature-controlled transport plays in maintaining their quality and potency. Without this invisible hero, the journey from lab to patient would be fraught with risks and uncertainties.

Key Logistics considerations

Even with the most meticulous planning, challenges can arise in the transportation of sensitive pharmaceutical products or materials which could jeopardise a clinical trial. Outside factors could range from delays due to traffic, customs processing, or even adverse weather conditions.

There are many factors which require careful consideration in order to implement smooth transportation. These include the types of products being transported and the temperatures at which they have to be maintained, the packaging and handling of those products in addition to the mode of transport – refrigerated trucks, vans fitted with specialist temperature control packaging, or airfreight with temperature control capabilities and, of course, ensuring that the whole process complies with regulatory requirements.

Temperature Control

Products being shipped can range from tablets to insulin, vaccines, blood samples and biological tissue. Each product requires a unique storage solution and temperatures can range from ambient to refrigerated, frozen, ultra-low and even cryogenic:

  • Ambient (non-controlled)
  • Ambient (+15 to +25C)
  • Refrigerated (+2 to +8C)
  • Frozen (-25 to -15C)
  • Ultra-Low (-80C to -60C)
  • Cryogenic

 Specialised Packaging

Specialised packaging is essential to maintain temperature consistency throughout transportation. Delivery vehicles are fitted with environmentally controlled compartments to maintain temperatures. Shipping systems which include vacuum insulated panels can be used to provide precise heat insulation and are ideal for use in compact spaces.

Bio-specimens require careful transportation at ultra-low temperatures. Shipping vessels containing liquid nitrogen or dry ice provide the most reliable and efficient transportation.

Real-time temperature sensors and logging systems are essential to monitor and ensure that products are kept within their required temperature ranges throughout the journey. These can be placed inside product boxes and upon examination at their destination, will alert the receivers to any temperature deviations. In addition, GPS tracking provides instant, product location updates which can be useful in case of any delays.

Supply Chain Network

Establishing a reliable supply chain network and working with partners who are experienced in the safe handling and transportation of pharmaceutical products across multiple modes of transport, whilst complying with Good Distribution Practices will mean that sponsors can ship in full confidence with complete peace of mind

Customs Clearance

For international trials, navigating customs clearance can be a complex and time-consuming process. It is essential that the logistics provider is familiar with the regulations application for each country involved and ensure that all necessary documentation is in order in order to avoid any cross-border delays.

Mitigating Risk

Contingency planning is a critical part in providing a reliable logistics service and back-up plans should always be in place in case of unforeseen circumstances. This is where it is essential to establish clear communication channels, protocols and data access across all stakeholders to ensure a timely flow of information and a swift, co-ordinated response to any issues.

Working with Oximio

At Oximio we pride ourselves on delivering a flexible and tailored, temperature-controlled logistics solutions for clinical trials. With 20 years’ experience, we benefit from highly skilled and fully qualified teams across Europe, the Middle East and Africa, further enhanced by a partner network depot stretching across Asia and the US.

To find out how our global supply chain solutions can play a key role in your clinical research, please contact us.

Further Reading